General Information
Revision date
2010-07-30
Product name
FOLOTYN (formulated pralatrexate)
Product Synonyms
N-{4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}-L-glutamic acid, (2S)-2- [[4-[(1RS)-1-[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl]benzoyl]
Chemical name
Folic acid analog
CAS No.
146464-95-1
1.2.1 Relevant identified uses
Active pharmaceutical ingredient; indicated for the treatment of relapsed or of the substance or
Icons in SDS
Company Information
company name
Allos Therapeutics, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
msds@ALLOS.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H302, H341, H360FD, H372
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
2.1 Classification of the substance or mixture
Regulation (EC) 1272/ Reproductive Toxicity - Category 1A. Germ Cell Mutagenicity - Category 2.. 2008 [GHS] Acute toxicity - oral - Category 4. Specific Target Organ Toxicity (repeated exposure) - Category 1. Directive 67/548/EEC T - R60 (Repro. Cat. 1), R61 (Repro. Cat. 1), R48/23/25, R68 (Muta. Cat. 3), R22 or 1999/45/EC …continued
Signal word
Danger Caution …continued US Hazard overview Cytotoxic drug. May adversely affect the developing fetus and/or cause adverse reproductive effects. May cause birth defects. May cause hematological system, gastrointestinal system, liver and bone marrow damage. May be genotoxic. May be harmful if swallowed. Note This substance is classified as dangerous/hazardous according to Directive 67/548/ EEC, Regulation EC No 1272/2008 (EU CLP), and applicable US regulations. The EU symbol/indicator of danger, R Phrases and Safety Advice are based on Directive 67/548/EEC or 1999/45/EC. See Section 16 for full text of EU and GHS classifications.
CLP CLASSIFICATION
H302 - Harmful if swallowed. H341 - Suspected of causing genetic defects.
Hazard statements
H360FD - May damage fertility. May damage the unborn child. H372 - Causes damage to hematological system, gastrointestinal system, liver and bone marrow through prolonged or repeated exposure. CLP/GHS P201 - Obtain special instructions before use. P202 - Do not handle until all safety
Precautionary statements
precautions have been read and understood. P260 - Do not breathe dust. P264 Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P281 - Use personal protective equipment as required. P308 + P313 - If exposed or concerned get medical advice/attention. P301+P312 IF SWALLOWED: Call a Poison Center or doctor/physician if you feel unwell. P314 - Get medical advice/attention if you feel unwell. P330 - Rinse mouth. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations. EU symbol/indication of danger T- Toxic. Risk (R) Phrase(s) R60 - May impair fertility. R61 - May cause harm to the unborn child. R68 - Possible risk of irreversible effects. R48/23/25 - Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed. R22 - Harmful if swallowed. S22 - Do not breathe dust. S36/37 - Wear suitable protective clothing and gloves. S53 - Avoid exposure - Obtain special instructions before use.
2.3 Other hazards
Pralatrexate is a cytotoxic anticancer agent. The most commonly occurring adverse effects with therapeutic use of pralatrexate include mucositis, thrombocytopenia, nausea and fatigue. Other adverse effects may include bone marrow suppression, hematological toxicity, gastrointestinal toxicity and liver toxicity. Reproductive, developmental and genotoxic effects have been observed in humans exposed to the mechanistically and structurally related compound, methotrexate.
